FDA 510(k) Searchable Database - Search 175,000+ Clearances

Search 175,000+ FDA 510(k) clearances by K-number, device name, manufacturer or product code. Includes real review time data, denied submission rates and regulatory intelligence not available on any other searchable 510(k) database.

175,972 clearances · 1976 to present · Updated monthly from FDA records

Filters: Cleared only ×
175,468 results
72865–72888 of 175,468
Search insights Median review: 84d Cleared: 100% Top manufacturer: Abbott Laboratories Lead specialty: General & Plastic Surgery
Cleared Feb 21, 2003
PRIMELUNG
K024149 · JAK
Accuimage Diagnostics Corp.
Radiology · 67d
Cleared Feb 21, 2003
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT...
K024193 · MMI
Ortho-Clinical Diagnostics
Chemistry · 63d
Cleared Feb 21, 2003
TERUMO SURGUARD SAFETY SYRINGE
K024249 · MEG
Terumo Medical Corp.
General Hospital · 60d
Cleared Feb 21, 2003
THE VEST AIRWAY CLEARANCE SYSTEM, MODEL 104
K024309 · BYI
Advanced Respiratory
Anesthesiology · 59d
Cleared Feb 21, 2003
OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)
K030045 · DIH
Olympus America, Inc.
Chemistry · 46d
Cleared Feb 21, 2003
CARBO/OPTIMED BRAND ACUPUNCTURE NEEDLES
K030190 · MQX
Suzhou Sen Sen Medical Supplies , Ltd.
General Hospital · 31d
Cleared Feb 21, 2003
MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER
K030240 · GCJ
Computer Motion, Inc.
General & Plastic Surgery · 29d
Cleared Feb 21, 2003
MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM
K030241 · KWP
Blackstone Medical, Inc.
Orthopedic · 29d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM EXTENDED OMNIAXIAL CONNECTORS (CO05 & CO07)
K030252 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
ORIA SPINAL CLIP SYSTEM, LENGTHENED LATERAL CONNECTOR, MODEL AL06
K030253 · KWP
Ortho Tec, LLC
Orthopedic · 28d
Cleared Feb 21, 2003
TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL
K030286 · NBC
Biosite Incorporated
Chemistry · 24d
Cleared Feb 21, 2003
JASUN, MODELS DT-01F AND DT-11F
K030361 · FLL
Hangzhou Hua'An Medical & Health...
General Hospital · 18d
Cleared Feb 20, 2003
XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
K020595 · JWZ
Xenotope Diagnostics, Inc.
Microbiology · 363d
Cleared Feb 20, 2003
MEDLITE Q-SWITHCED LASER
K022709 · GEX
Continuum Electro-Optics, Inc.
General & Plastic Surgery · 190d
Cleared Feb 20, 2003
MAGIC INFUSION CATHETER
K023351 · KRA
Advanced Interventional Technologies,...
Cardiovascular · 136d
Cleared Feb 20, 2003
ESSEX ASPIRATION/IRRIGATION INSTRUMENT WITH POSITIONING GUIDE, MODEL SY-1400
K023630 · GCJ
Guidant Corporation, Cardiac Surgery
General & Plastic Surgery · 115d
Cleared Feb 20, 2003
LUNEAU STERILE TONOMETER SEPARATION PRISMS
K023838 · HKY
Luneau SA
Ophthalmic · 94d
Cleared Feb 20, 2003
DUAL YELLOW LASER, MODEL D10B
K023899 · GEX
Norseld Pty., Ltd.
General & Plastic Surgery · 90d
Cleared Feb 20, 2003
WILSON-COOK ENDOSCOPIC CLIPPING DEVICE
K023903 · PKL
Wilson-Cook Medical, Inc.
Gastroenterology & Urology · 90d
Cleared Feb 20, 2003
SMALL BARD VENTRALEX PATCH
K024008 · FTL
C.R. Bard, Inc.
General & Plastic Surgery · 78d
Cleared Feb 20, 2003
ADVANCE LESS CONFORMING TIBIAL COMPONENT
K030193 · HRY
Wrightmedicaltechnologyinc
Orthopedic · 30d
Cleared Feb 20, 2003
DYONICS POWER CONTROL UNIT
K030196 · HRX
Smith & Nephew, Inc.
Orthopedic · 30d
Cleared Feb 20, 2003
ACUMATCH P-SERIES POROUS PRESS-FIT FEMORAL COMPONENT
K030236 · LPH
Exactech, Inc.
Orthopedic · 28d
Cleared Feb 20, 2003
GELBFISH FLEX VASCULAR DILATOR
K030260 · DRE
Vascumetrix, LLC
Cardiovascular · 27d